F Drescher1, W Weber1,2, A Berlis3, S Rohde4, A Carolus5, S Fischer6. 1. From the Knappschaftskrankenhaus Bochum (F.D., W.W., S.F.), Universitätsklinik, Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie, Nuklearmedizin, Bochum, Germany. 2. Knappschaftskrankenhaus Recklinghausen Klinik für Radiologie Neuroradiologie und Nuklearmedizin (W.W.), Recklinghausen, Germany. 3. Klinikum Augsburg (A.B.), Klinik für Diagnostiche Radiologie und Neuroradiologie, Augsburg, Germany. 4. Klinikum Dortmund (S.R.), Klinik für Radiologie und Neuroradiologie, Dortmund, Germany. 5. Knappschaftskrankenhaus Bochum (A.C.), Universitätsklinik, Klinik für Neurochirurgie, Bochum, Germany. 6. From the Knappschaftskrankenhaus Bochum (F.D., W.W., S.F.), Universitätsklinik, Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie, Nuklearmedizin, Bochum, Germany sebif101@googlemail.com.
Abstract
BACKGROUND AND PURPOSE: Flow diversion emerged as a crucial treatment option for intracranial aneurysms. We report a multicenter retrospective analysis of the safety and efficacy in the treatment of intracranial aneurysms with the Flow-Redirection Endoluminal Device (FRED) flow diverter, a dual-layer flow-modulation device. MATERIALS AND METHODS: All intracranial aneurysms treated with the FRED between March 2013 and February 2016 at 4 neurovascular centers were included. Angiographic and clinical results were retrospectively analyzed, including all follow-up examinations. Aneurysms were unruptured in 44 cases, whereas 8 treatments were due to an acute SAH from the target aneurysm. RESULTS: Successful implantation of the FRED was possible in 96.2% (50/52) of cases. At 3-month follow-up, complete occlusion was determined in 58.1% (25/43) and near-complete in 25.6% (11/43). At 12-month follow-up, aneurysm occlusion was complete in 75.0% (27/36) and near-complete in 22.2% (8/36). The overall acute and late thromboembolic and hemorrhagic complication rate was 17.3% (9/52), with a permanent treatment-related morbidity and mortality of 4.0% (2/50) and 2.0% (1/50), respectively, to date. CONCLUSIONS: The FRED device offers an effective tool in the treatment of intracranial aneurysms. The dual-layer design promotes contemporary and stable long-term occlusion rates. Sufficient device expansion should be documented by angiographic CT. Further studies might help to identify a more optimal antiplatelet regimen to avoid thromboembolic complications during the follow-up period.
BACKGROUND AND PURPOSE: Flow diversion emerged as a crucial treatment option for intracranial aneurysms. We report a multicenter retrospective analysis of the safety and efficacy in the treatment of intracranial aneurysms with the Flow-Redirection Endoluminal Device (FRED) flow diverter, a dual-layer flow-modulation device. MATERIALS AND METHODS: All intracranial aneurysms treated with the FRED between March 2013 and February 2016 at 4 neurovascular centers were included. Angiographic and clinical results were retrospectively analyzed, including all follow-up examinations. Aneurysms were unruptured in 44 cases, whereas 8 treatments were due to an acute SAH from the target aneurysm. RESULTS: Successful implantation of the FRED was possible in 96.2% (50/52) of cases. At 3-month follow-up, complete occlusion was determined in 58.1% (25/43) and near-complete in 25.6% (11/43). At 12-month follow-up, aneurysm occlusion was complete in 75.0% (27/36) and near-complete in 22.2% (8/36). The overall acute and late thromboembolic and hemorrhagic complication rate was 17.3% (9/52), with a permanent treatment-related morbidity and mortality of 4.0% (2/50) and 2.0% (1/50), respectively, to date. CONCLUSIONS: The FRED device offers an effective tool in the treatment of intracranial aneurysms. The dual-layer design promotes contemporary and stable long-term occlusion rates. Sufficient device expansion should be documented by angiographic CT. Further studies might help to identify a more optimal antiplatelet regimen to avoid thromboembolic complications during the follow-up period.
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